Neelam Sharma, Sukhbir Singh, Narish Laller, Sandeep Arora
Neelam Sharma, Sukhbir Singh*, Narish Laller, Sandeep Arora
Chitkara College of Pharmacy, Chitkara University, Punjab, India.
Volume - 13,
Issue - 4,
Year - 2020
Rheumatoid arthritis is an autoimmune disease which could lead to severe joint damage and disability. Various strategies for treatment of rheumatoid arthritis produce serious adverse effects which require continuous monitoring. Consequently, herbal treatments are considered safer alternative to manage rheumatoid arthritis. In this investigation, Trigonella foenum-graecum ether extracts containing linolenic acid for anti-inflammatory and anti-arthritic activity was produced. Furthermore, Trigonella foenum-graecum ether extract phytosomes (TFG-PH) were developed by thin-film hydration technique using L-a-Phosphatidylcholine and cholesterol followed by optimization using central composite design to determine optimized composition and processing conditions for optimized TFG-PH. Quadratic equation was developed for % entrapment efficiency (Y1) and % yield (Y2) to evaluate the effect of independent variables on response parameters. Y1 = 69.75 + 9.21 X1 + 0.5191 X2 + 1.61 X3 + 1.19 X1X2 + 0.5488 X1X3- 1.06 X2X3 - 3.56 X12 -0.7654 X22 - 2.39 X32; Y2 = 61.52 + 8.99 X1 + 1.32 X2 + 1.56 X3 + 1.42 X1X2 + 0.47 X1X3 - 0.4025 X2X3 - 4.29 X12 -1.10X22 - 2.39 X32. It was found that, % entrapment efficiency and yield rapidly increased with increase in phosphatidylcholine concentration. The desirability function was explored using Design-Expert software (Trial Version 188.8.131.52, Stat-Ease Inc., MN) to achieve optimized TFG-PH on set paradigm of maximizing entrapment efficiency (% w/v) and yield (% w/v). The composition and processing conditions for optimized TFG-PH as explored using Design-Expert software (Trial Version 184.108.40.206, Stat-Ease Inc., MN) was phosphatidylcholine (X1 = 1.31 % w/v), cholesterol (X2 = 6.218 % w/v) and rotation speed (X3 = 94.5 rpm). Desirability function for optimized TFG-PH was found 0.918 which will produce entrapment efficiency and yield of 72.18 % w/v and 64.89 % w/v, respectively. Furthermore, optimized TFG-PH-based transparent, homogeneous, moisturizing, non-greasy, spreadable and stable cream was manufactured which could generate superior therapeutic effect owing to enhanced permeability and skin retention potential of phytosomes without producing any adverse effect.
Cite this article:
Neelam Sharma, Sukhbir Singh, Narish Laller, Sandeep Arora. Application of Central Composite Design for Statistical Optimization of Trigonella foenum-graecum Phytosome-Based Cream. Research J. Pharm. and Tech 2020; 13(4):1627-1632. doi: 10.5958/0974-360X.2020.00295.4
1. Shaji J, Shinde A. Formulation and evaluation of floating pulsatile microspheres of aceclofenac for rheumatoid arthritis. Research Journal of Pharmacy and Technology. 2011; 4(12): 1877-1881.
2. Sindhu G, Ratheesh M, Shyni GL, Nambisan B, Helen A. Anti-inflammatory and antioxidative effects of mucilage of Trigonella foenum graecum (Fenugreek) on adjuvant induced arthritic rats. International Immunopharmacology. 2012; 12(1): 205-211.
3. Priti L, Sayyad Heen S. An Overview of phytosomes as an advanced herbal drug delivery system. Research Journal of Topical and Cosmetic Sciences. 2013; 4(2): 65-66.
4. Selvaraju K, Arulkumaran KSG, Karthick K, Prabhu KV, Preetha JP, Arrivukkarasu R. Phytosomes-An advanced herbal technology. Research Journal of Pharmacognosy and Phytochemistry. 2011; 3(5): 191-194.
5. Pundarikakshudu K, Shah DH, Panchal AH, Bhavsar GC. Anti-inflammatory activity of fenugreek (Trigonella foenum-graecum Linn) seed petroleum ether extract. Indian Journal of Pharmacology. 2016; 48(4): 441-444.
6. Nisha, Rao PB. Trigonella foenum-graecum: A common indian spice with medicinal properties. Research Journal of Pharmacy and Technology. 2016; 9(2): 173-176.
7. Meena AK, Singh B, Singh U, Yadav AK, Nagariya A, Sharma K. Therapeutic uses and pharmacological action of Trigonella foenum-Graecum Linn. Research Journal of Pharmacology and Pharmacodynamics. 2010; 2(2): 172-175.
8. Mavani PB, Patel GM, Shukla AK, Shelat PK. Design, development and optimization aceclofenac effervescence tablets by central composite design. Research Journal of Pharmaceutical Dosage Forms and Technology. 2015; 7(1): 15-20.
9. Suresh P, Kavita CH, Babu SM, Reddy VP, Latha AK. Effect of ethanol extract of Trigonella foenum-graecum (Fenugreek) seeds on Freund's adjuvant induced arthritis in albino rats. Inflammation. 2012; 35(4): 1314-1321.
10. Liu Y, Kakani R, Nair MG. Compounds in functional food fenugreek spice exhibit anti-inflammatory and antioxidant activities. Food Chemistry. 2012; 131(4): 1187-1192.
11. Julie MJ, Athira AK, Verjina CU, Deepa TV, Saritha AS. Formulation and evaluation of antiaging phytosomal gel. Asian Journal of Pharmaceutical and Clinical Research. 2018; 11(3): 409-423.
12. Jangde R, Singh D. Preparation and optimization of quercetin-loaded liposomes for wound healing, using response surface methodology. Artificial Cells, Nanomedicine, and Biotechnology, 2016; 44(2): 635-641.
13. Ruozi B, Tosi G, Forni F, Vandelli AM. Ketorolac tromethamine liposomes: Encapsulation and release studies. Journal of Liposome Research. 2005; 15(3-4): 175-185.
14. Sharma N, Singh S, Arora S, Madan J. Quality-by-design approach for development and optimization of nefopam hydrochloride loaded poly-ε-(caprolactone) and poly-3-hydroxybutyrate microspheres. International Journal of Pharmaceutical Sciences and Research, 2017; 8(12): 5111-5121.
15. Sumalath B, Babu DJ, Venkatanarayana A, Reddy PR, Sruthi PD. Experimental investigation on biosorption of chromium from aqueous solution using citrus limonium peel: optimization of process parameters using central composite design. Research Journal of Pharmacy and Technology. 2018; 11(12): 5253-5264.
16. Anwar E, Farhana N. Formulation and evaluation of phytosome-loaded maltodextrin-gum arabic microsphere system for delivery of camellia sinensis extract. Journal of Young Pharmacist, 2018; 10(2): s56-s62.
17. Pande SD, Wagh AS, Bhagure LB, Patil SG, Deshmukh AR. Preparation and evaluation of phytosomes of pomegrane peels. Research Journal of Pharmacy and Technology. 2015; 8(4): 416-422.
18. Singh S, Singla YP, Arora S. Statistical, diagnostic and response surface analysis of nefopam hydrochloride nanospheres using 35 Box-Behnken design. International Journal of Pharmacy and Pharmaceutical Sciences. 2015; 7(10): 89-101.
19. Singh S, Singla YP, Arora S. Development and statistical optimization of nefopam hydrochloride loaded nanospheres for neuropathic pain using Box-Behnken design, Saudi Pharmaceutical Journal, Saudi Pharmaceutical Journal. 2016; 24: 588-599.
20. Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical Experimental Design. first ed. Marcel Dekker Inc New York 1999.
21. Myers WR. 2003. Response Surface Methodology. In: Chow, SC, ed. Encyclopedia of Biopharmaceutical Statistics. New York: Marcel Dekker 858-69.
22. Zhou YZ, Alany RG, Chuang V, Wen J. Optimization of PLGA nanoparticles formulation containing L-DOPA by applying the central composite design. Drug Development and Industrial Pharmacy. 2013; 39(2): 321-330.
23. Pereira A, Mallya R. Formulation and evaluation of a photoprotectant cream containing Phyllanthus emblica extract-phospholipid complex. Journal of Pharmacognosy and Phytochemistry. 2015; 4(2): 232-240.
24. Arora S, Sharma N, Mahajan A, Kaur J, Singh S. Development, physicochemical characterization and in-vitro evaluation of herbal sunscreen lotion. Journal of Pharmaceutical Technology, Research and Management. 2015; 3(2): 113-125.
25. Panda, P. Formulation and evaluation of topical dosage form of Alangium salvifolium Linn and their wound healing activity. Asian Journal of Pharmaceutical Sciences and Research. 2011; 1: 10-23.
26. Multimer M. Spreadability determination by an apparatus. Journal of American Pharmacists Association. 1956; 45: 212-214.
27. Patel NA, Patel NJ, Patel RP. Comparative development and evaluation of topical gel and cream formulations of psoralen. Drug Discovery and Therapeutics. 2009; 3: 234-242.
28. Jain BD, Padsalg A, Patel K, Mokale V. Formulation, development and evaluation of fluconazole gel in various polymer bases. Asian Journal of Pharmaceutics. 2007; 1: 63-68.
29. Maulvi FA, Thakkar VT, Soni TG, Gandhi TR. Optimization of aceclofenac solid dispersion using box-behnken design: in-vitro and in-vivo evaluation. Current Drug Delivery. 2014; 11(4): 1-12.
30. Sharma N, Arora S, Madan J. Nefopam hydrochloride loaded microspheres for post-operative pain management: synthesis, physicochemical characterization and in-vivo evaluation. Artificial Cells Nanomedicine and Biotechnology. 2018; 46(1):138-146.
31. Koshti AR, Jadhav SB, Bari MM, Barhate SD. Formulation optimization and evaluation of orodispersible tablet of taste masked fexofenadine hydrochloride. Asian Journal of Pharmacy and Technology. 2019; 9(3): 212-219.
32. Jadhav SB, Koshti AR, Bari MM, Barhate SD, Formulation optimization and Evaluation of Transdermal patch of losartan potassium containing DMSO as permeation enhancer. Asian Journal of Pharmacy and Technology. 2019; 9(3): 220-227